Kornimate/medical-research-clean huggingface dataset:
benefits of stroke treatment delivered using a mobile stroke unit

Conditions: Acute Ischemic Stroke

Summary: the primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a mobile stroke unit (msu) with subsequent transfer to a comprehensive stroke center (csc) emergency department (ed) for further management, to standard pre-hospital triage and transport by emergency medical services (ems) to a csc ed for evaluation and treatment (standard management-sm).

there are many ways that use of a msu might prove valuable in stroke patients, but we will focus on acute ischemic stroke (ais) and treatment with iv tissue plasminogen activator (tpa) within 4.5 hours of symptom onset since that is the most evidence based effective emergency treatment for the most prevalent stroke diagnosis. we hypothesize that the msu pathway will result in an overall shift towards earlier evaluation and treatment, particularly into the first hour after symptom onset, leading to substantially better outcome. we also hypothesize that as a result of improved clinical outcomes resulting from earlier treatment, the costs of a msu program will be offset by a reduction in the costs of long term stroke care and increase in quality adjusted life years, thereby supporting more widespread use of this technology. to make msu deployment more practical, we will confirm that a vascular neurologist (vn) on board the msu can be replaced by a remote vn connected to the msu by telemedicine (tm) thereby reducing manpower requirements and costs. the successful completion of this project will provide data on important outcomes and costs associated with the use of msu vs sm in the united states (u.s.) that will help determine the value of integrating msus into the pre-hospital environment in this country. successfully addressing our three specific aims (time saved/ complications encountered, utility of tm, and cost effectiveness) will provide critical information that will be needed to determine if and how a subsequent more definitive study should be conducted. we anticipate that emanating from this exploratory study would be a larger multicenter trial carried out in both urban and rural u.s. pre-hospital environments, with treatment orchestrated via tm, and having sufficient power to determine a difference in long term outcome and costs between patients managed on the two pathways, following a study design that will be tested in this exploratory trial. the present study, therefore, is the necessary first step in a process which may dramatically modify the way that acute stroke patients are managed in the u.s.

Eligibility criteria:
inclusion criteria: * last seen normal within 4hr 30 min of symptom onset * history and physical/neurological examination consistent with acute stroke * no tpa exclusions per guidelines, prior to ct scan or baseline labs * informed consent obtained from patient (if competent) or legal representative. exclusion criteria: -none

Keywords: stroke tpa emergency medical service ems mobile ct scan
efficacy and safety assessment of t4032 (unpreserved bimatoprost 0.01%) versus lumigan® 0.01% in ocular hypertensive or glaucomatous patients

Conditions: Glaucoma; Ocular Hypertension

Summary: the main study purpose is to demonstrate the non-inferiority of t4032 compared to lumigan® 0.01% in terms of efficacy.


Eligibility criteria:
inclusion criteria: * informed consent dated and signed. * both eyes diagnosed open-angle glaucoma or ocular hypertension exclusion criteria: * history of trauma, infection, clinically significant inflammation within the previous 3 months * known or suspected hypersensitivity to one of the components of the investigational medicinal product(s) * pregnancy or breast-feeding
effectiveness of modified functional appliance with expander

Conditions: Class II Malocclusion

Summary: this clinical trial compares the effectiveness of a myofunctional appliance that uses a clear and modified twin block appliance with an expander made from 2mm biocompatible polyethylene terephthalate modified with glycol thermoplastic material with a conventional twin block appliance with an expander. the trial will be conducted on adolescent patients with class ii division 1.

in a multicenter single-blinded randomized clinical trial study with two-arm parallel groups, a computer random generator will develop a simple randomization with an equal allocation ratio (1:1) and without stratification. the investigator will initially assess the patients for eligibility to be included in the study. those who will meet the inclusion criteria, the parents will be informed about the nature of the study verbally to get the initial approval for participation. then they will be provided with the patient information sheet and consent form. according to the sample size calculation, 48 patients will be recruited (24 for each group), and impressions and lateral cephalometric radiography will be taken before treatment and bite registration then the appliance inserted, and the patient will be checked every two weeks for expansion and every four weeks for overjet recording. the treatment will be continuing for 6 months to take final records. the collected data will include cephalometric evaluation, clinical evaluation, scanned upper model evaluation, and finally patient satisfaction from the appliance. data will be analyzed using statistical package for social sciences for windows, version 26.0 including descriptive statistic (number, mean, and standard deviation), reliability statistic (interclass correlation coefficient), and inferential statistics (independent samples t-test).

Eligibility criteria:
inclusion criteria: 1. patients' age at the start of treatment: at growth spurt \[in stage 2 (acceleration) - 3 (transition) of cervical vertebral maturation\]. 2. skeletal and dental relationships: skeletal class ii with normal maxilla and retrognathic mandible. moderate to severe dental class ii division 1 malocclusion with overjet ≥ 8 mm. 3. horizontal/normal growth pattern. 4. convex profile with decreased or normal lower facial height (clinically and radiographically). 5. well-aligned/mild crowding of maxillary and mandibular dental arches. 6. good oral health free from caries and periodontal problems at the start of treatment. exclusion criteria: 1. patients with vertical growth pattern or backward mandibular rotation tendency. 2. patients with open bite 3. patients with obvious facial asymmetry. 4. patients with orofacial clefting. 5. patients with bad oral habits. 6. active periodontal disease.

Keywords: twin block thermoplastic material clear expander, adolescent clinical trial
antialbuminuric effects of valsartan and lisinopril

Conditions: Hypertension; Early Diabetic Nephropathy

Summary: title: antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up. objective: to evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients. hypothesis: combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies.. design: multicentric, randomized, open label, parallel group, active controlled. dose / regimen: valsartan 320 vs lisinopril 40 vs valsartan/lisinopril 160/20 primary endpoint: antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. description % of change in albuminuria from baseline at 20 weeks. secondary endpoint : to investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in gfr (cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and cornell-sokolow method.


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 40-75 years, * chronic nephropathy, as defined by a serum creatinine concentration of \> 1.3 mg/dl or calculated glomerular filtration rate of \> 30 ml/min/1.73 m2. * persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not \> 1000 mg/ 24h. (for a minimum of three months). * hypertensive patients not adequately controlled with or without treatment (controlled: \<130/80 mmhg). * written informed consent to participate in the study prior to any study procedures. exclusion criteria: * immediate need for renal replacement therapy. * treatment resistant oedema or nephrotic syndrome. * need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs. * albuminuria greater than 1000mg /24h and or less than 20mg/24h. * total cholesterol \< 135mg/dl or not need for statins treatment. * renovascular hypertension * malignant hypertension * mi, cerebrovascular accident within last year, severe peripheral vascular disease, chf, chronic hepatic disease. * angiotensin converting enzyme inhibitors and angiotensin ii receptors blockers within one month prior to randomization. * a serum creatinine concentration \>265 umol/l

Keywords: valsartan lisinopril albuminuria diabetic nephropathy
tetracaine versus lidocaine gel for anesthetic effect and comfort in patients undergoing lasik

Conditions: Pain

Summary: in this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. the two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. this study will show if one type of anesthesia is preferred over another by patients getting lasik. before your lasik procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. in the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). after your lasik surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your lasik to get more details about your experience. \*of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. this means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine. when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. this is important to note since the randomization refers to eye for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).

outcome measures involve comparing the right eye and left eye for severity of 12 different symptoms, that are recorded in severity on a 1-5 scale. a score of 1 means no symptoms and 5 means severe. the 12 measurements include sharp pain, dull ache, pain during movement, stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation, pressure sensation, decreased vision, and blurry vision.

Eligibility criteria:
inclusion criteria: * healthy volunteers of age 18 years or greater exclusion criteria: * previous reaction/allergy to the same drug class * prior ocular surgery * active facial injuries * any active current ophthalmological disease * history of diabetes * any current non- over the counter pain medication * inability to complete the questionnaire. * economically or educationally disadvantaged persons, prisoners, or children * patients with fluctuating or impaired decision-making capacity * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

Keywords: efficacy comfort
changes in prostaglandin levels in laser cataract surgery (lcs) subject to laser prevalence

Conditions: Age Related Cataracts

Summary: the investigational device is an approved femtosecond laser (fsl) device with an integrated imaging system to perform certain steps of the cataract procedure. the fsl will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. cataract surgery will be performed in subjects who have signed an informed consent form. aqueous humor will be collected and screening will be performed for total prostaglandin and prostaglandin e2 via en-bloc enzyme-linked immunosorbent assay (elisa)-kit.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation * age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible) * preoperative pupil dilation in mydriasis ≥ 6.5 mm exclusion criteria: * preceding ocular surgery or trauma * recurrent intraocular inflammation of unknown etiology * uncontrolled glaucoma * uncontrolled systemic or ocular disease * blind fellow eye * microphthalmus * corneal abnormality * history of uveitis/iritis * iris neovascularization * pseudoexfoliation * proliferative diabetic retinopathy * pregnancy * lactation * females of childbearing age: not included

Keywords: laser cataract surgery
niv strategies for rds in preterm infants. niv (non invasive ventilation), rds (respiratory distress syndrome)

Conditions: RDS of Prematurity

Summary: the purpose of this study is to determine whether two different strategies of non invasive ventilation (niv) have different effect on length and failure of niv support in preterm infants with respiratory distress syndrome (rds).

a randomized control trial (rct) conducted in two tertiary level neonatal intensive care unit (nicu). ethical approval is needed. informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. all inborn very low birth weight (vlbw) infants (birthweight less than 1500 g and gestational age \< 32 weeks) with signs of rds, spontaneously breathing and only supported by nasal-continuous positive airway pressure (ncpap) in nicu, will be randomized within the first 2 hours of life to receive two different non invasive ventilation (niv) strategies: nasal synchronized intermittent positive pressure ventilation (n-sippv) or bilevel continuous positive airway pressure (bipap).

Eligibility criteria:
inclusion criteria: * all inborn vlbw infants (birthweight less than 1500 g and gestational age \< 32 wks) with signs of rds, spontaneously breathing and only supported by n-cpap, will be randomized within the first 2 hours of life to receive two different non invasive ventilation (niv) strategies. exclusion criteria: * apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth * newborns with genetic disease and/or with major congenital malformations * newborns for whom it was not obtained informed consent within two hours from birth

Keywords: niv nsippv bipap
portable emg-triggered hand robot for individuals after stroke

Conditions: Stroke

Summary: this is an interventional pilot study investigating the feasibility of using the hand of hope (hoh) device for individuals with decreased hand function after stroke.

the hoh will be used to provide hand training for patients with decreased hand ability after stroke. the hoh is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. the hoh works by detecting surface emg muscle activity and therefore requires active participation from the patient throughout the session. video games linked to the hoh device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

Eligibility criteria:
inclusion criteria: 1. diagnosis of stroke \> 6 months ago 2. presence of some active range of motion (arom) in the affected hand, measured by a score of at least 1 on the box and block test. 3. intact sensation in the affected hand 4. full passive range of motion (prom) in mass flexion and extension of the hand 5. mas score \< 3 for finger flexors and intrinsics 6. mas score \< 3 for finger extensors 7. visual tracking is intact in all directions 8. patient must be otherwise medically stable in the opinion of the principal investigator exclusion criteria: 1. patient is receiving active occupational or physical therapy for the affected arm 2. patient has joint contractures that prevent proper fit into the hoh device 3. patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as parkinson's or multiple sclerosis, or arthritis 4. it has been less than 3 months since last botulinum toxin injection in the affected arm

Keywords: stroke, robotics, hand rehabilitation
cognitive behavioral aggression treatment

Conditions: Aggression

Summary: aggressive behavior is a leading worldwide public health problem. despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. a rich literature suggests that aggression is associated with a tendency to interpret situations as threatening or hostile even when they are not. this process is governed by a prefrontal-limbic circuit in the brain. a goal of cognitive behavioral therapy is to reduce these kinds of hostile biases. preliminary data by the pi suggests a 12- session cognitive behavioral aggression treatment (cbat) may help reduce aggressive behavior and underlying hostile biases associated with affective aggression. to assess the efficacy of this treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of either cbat or supportive psychotherapy. all subjects will monitor their anger and aggressive behavior throughout the treatment electronic diaries. subjects will also complete questionnaires and computer tasks to assess anger, hostile biases and related processes 1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends. in addition, to understand the effects of cbat on the brain, subjects will have their brains scanned (functional magnetic resonance imaging) while they look at emotional pictures and complete computer tasks. the brain scans will occur once before treatment starts and once after treatment ends. our hypotheses are: 1. cbat will reduce anger, aggression and hostile biases more than supportive therapy. 2. cbat will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.


Eligibility criteria:
inclusion criteria: * three or more acts of physical aggression (assault / property destruction) in past six months * aggression related distress and/or impairment * meets criteria for intermittent explosive disorder exclusion criteria: * life history of dsm-iv axis bipolar disorder, schizophrenia, delusional disorder, organic disorder, or mental retardation * current dsm-iv major depressive episode, alcohol dependence or other drug dependence * current (past month) psychotropic medication use * current severe suicidal or homicidal ideation necessitating immediate medical intervention * current pregnancy or nursing, or existence of any medical condition that would deem the subject ineligible to undergo an fmri (e.g., metal pins) * two consecutive positive expired breathalyzer alcohol or urine drug toxicological screens * unable or unwilling to cooperate with study protocol (e.g., keep appointments, complete rating forms, read and understand informed consent).

Keywords: psychotherapy cognitive behavioral therapy aggression fmri behavioral intervention
taurine supplementation and training effects on energy metabolism, inflammation and oxidative stress in obese women

Conditions: Obesity

Summary: taurine supplementation researches have increased due to its antioxidant and anti-inflammatory actions, and its ability to modulate lipid metabolism by stimulating the expression of proteins that regulates mitochondrial biogenesis and increases respiratory function (pgc-1α and ppar) and irisin release when associated to exercise. since obesity can induce metabolic disorders including abnormal production of adipokines and activation of pro-inflammatory signaling pathways also mitochondrial metabolism dysfunction in the adipose tissue, the use of taurine would be a new strategy for obesity prevention and treatment. moreover, the association of taurine and exercise could improve exercise effects, promote higher energy expenditure and increase mitochondrial respiration, consequently resulting in weight loss. therefore, the present investigation aims to evaluate the effects of the association of taurine supplementation and a combined exercise training protocol (aerobic and strength) on resting energy expenditure, weight, body composition, blood markers of inflammation and oxidative stress, telomeres length, and mitochondrial function and the expression of genes that regulates energy metabolism and lipid oxidation in the white adipose tissue in obese women.

a double-blind placebo-controlled study was conducted with 24 obese women (32.9±6.3 years). capsules of taurine (3 grams) (gtau) or placebo (gp) were daily supplemented 2 hours before training. the training program was composed of aerobic and strength exercises during one hour, 3 times a week, for an 8-week period (intensity of 80% heart rate). the taurine supplemented group received only taurine capsules (3g/day) during 8 weeks. measurement of weight, hip and waist circumference, and body composition (by deuterium oxide) were performed before and after the intervention. resting energy expenditure and nutrients oxidation were assessed by calorimetry. in order to check the effects of the intervention, abdominal tissue biopsy will be performed for white adipose tissue analysis, evaluation of mitochondrial function and quantification of the expression of genes related to energy metabolism and lipid oxidation and taurine pathway; blood collection will be done for quantification of taurine levels, inflammatory (il-10, il-15, il-6, il-1, tnf-α, and crp), adipokines (adiponectin, adipsin, resistin, fetuin and leptin) and oxidative stress (gpx, sod and mda) markers. also, evaluation of telomere length was performed. body composition was evaluated by deuterium oxide method, weight, waist and hip circumference were accessed. all the measurements were performed before and after the intervention period.

Eligibility criteria:
inclusion criteria: * body mass index of 30 to 40 kg / m² * sedentary * no associated co morbidity exclusion criteria: * women who have a medical impediment to the practice of physical exercise * women that have undergone bariatric surgery * menopause, cancer or any metabolic disease * smokers * alcoholics * insulin-dependent diabetes